SOLO-Symbicort® in the Treatment of Persistent Asthma in Adolescents & Adults

Asthma Clinical Trial

Official title:

A Comparison of Symbicort® Single Inhaler Therapy (Symbicort® 200 Turbuhaler® 1 Inhalation b.i.d. Plus as Needed) & Conventional Best Practice for the Treatment of Persistent Asthma in Adolescents & Adults-a 26-Week, Randomised, Open-Label, Parallel Group, Multicentre Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00238784
• Other study ID #: D5890L00004
• Secondary ID: SOLO
• Status: Completed
• Phase: Phase 3
• First received: October 12, 2005
• Last updated: January 11, 2008
• Start date: May 2004
• Est. completion date: October 2005

Study information

• Verified date: January 2008
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare Symbicort Single Inhaler treatment with the Best Conventional Practice in patients with persistent asthma

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1300
• Est. completion date: October 2005
• Est. primary completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of asthma < 3 months

• Prescribed daily use of glucocorticosteroids for at least 3 months prior to Visit 1

Exclusion Criteria:

• Smoking history > 10 pack-years

• Asthma exacerbation requiring change in asthma treatment during the last 14 days prior to inclusion

• Any significant disease or disorder that my jeopardize the safety of the patient.

Additional inclusion and exclusion criteria will be evaluated by the investigator.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Budesonide/formoterol Turbuhaler

Locations

Country	Name	City	State
Canada	Research Site	Aldergrove	British Columbia
Canada	Research Site	Bolton	Ontario
Canada	Research Site	Brampton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first severe asthma exacerbation
Secondary	Number of asthma exacerbations
Secondary	Mean use of as-needed medication
Secondary	Prescribed asthma medication
Secondary	Patient reported Outcomes
Secondary	Health care resource use
Secondary	Safety: Adverse Events, Serious Adverse Events and discontinuations due to Adverse Events
Secondary	Induced sputum will be sampled from a subset of patients
Secondary	All variables assessed over the 6 months treatment period

External Links

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